Director, Quality

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply.

As a member of the senior management team, ensure an effective Pharmaceutical Quality Management system is in place. The Quality Director will provide leadership and daily management of the site Quality Assurance, Validation and Quality Control Departments. The Quality Director will also be responsible for providing support to both the Dartford site business unit (BU) operations, as well as to the corporate Quality function.

The Role:

• To ensure the Quality function complies with Health, Safety and Environmental requirements and employees adhere to the “Standards of Business Conduct.”
• To determine, establish and maintain comprehensive systems that establish document and monitor GMP Quality and ISO standards that meet Catalent, Regulatory and Customer requirements.
• To ensure that the Dartford site complies with all Applicable Laws relative to Good Manufacturing Practice and ensure that all regulatory licenses are maintained and renewed in line with different countries' requirements as appropriate for the business.
• Manage the team against the site and Quality strategy objectives.
• To develop a Quality culture on site, such that the Quality team provides leadership and coaching to ensure GMP best practices are embedded throughout the site.
• To continually review the operation of the Quality function on site, and deliver a programme of continual improvement.
• To manage the Quality budget, ensuring well-defined resource modelling.
• To act as a primary contact for senior Quality professionals within our customer organizations to ensure compliance and customer service standards are met.
• Other duties as assigned.

The Candidate:

• Degree in Biology, Chemistry, Pharmacy or an equivalent qualification.
• To be eligible to act as a Qualified Person is preferable but not essential.
• Must have 10+ years’ experience of successfully leading a customer-focused quality function including QA, QC and batch release within an API manufacturing environment or pharmaceutical manufacturing environment.
• Has participated in managing and fronting Regulatory Inspections from both EU and US Regulatory agencies such as MHRA, FDA, etc.
• Demonstrable leadership experience at Catalent may be considered in place of external experience.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, confirming your request for an accommodation and including the job number, title and location.